Tranexamic Acid and Ethamsylate For Preventing PPH in Patient Undergoing LSCS at High Risk For PPH

Tranexamic Acid and Ethamsylate For Preventing Post Partum Hemorrhage in Patient Undergoing LSCS at High Risk For Post PartumHemorrhage : A Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02604719

Enrollment

Registered

2015-11-13

Start date

2015-11-30

Completion date

2016-07-31

Last updated

2015-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

Brief summary

The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk for post partum hemorrhage

Detailed description

Research Question: Is the combination of Tranexamic acid and Ethamsylate is more effective than oxytocin alone for preventing postpartum hemorrhage if they are given after delivery of the fetus ?

Interventions

DRUGTranexamic Acid and Ethamsylate

The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

1. Women undergoing elective caesarean section 2. Patient having one or more risk factor for PPH * Multiple pregnancy * Polyhydramnios (AFI \>25cm) * Macrocosmic baby (\>4.5 Kg) * Prolonged , augmented and obstructed labour * Obese patients(BMI \>30) * Premature rapture of membranes * Previous history of PPH 3. Age ≥18 years 4. Gestational Age ≥ 35 Weeks 5. Informed Oral Consent From The Patient

Exclusion criteria

1. History of venous thrombosis (DVT and/or Pulmonary embolism) OR arterial thrombosis (angina pectoris , myocardial infarction, stroke) 2. History of epilepsy or seizure 3. Any Known Cardiovascular , renal or liver Disease 4. Autoimmune Diseases 5. Sickle Cell Disease 6. Severe hemorrhagic Disease 7. Placenta Previa. 8. Morbidly adherent Placenta 9. Abruptio placenta 10. Eclampsia, hemolysis, elevated liver enzymes, and low platelet count syndrome 11. Administration Of low molecular weight heparin or Anti platelets the week before delivery .

Design outcomes

Primary

Measure	Time frame	Description
PPH defined as blood loss ≥500 cc	the first 24hours	measured by pads placed under women buttocks

Secondary

Measure	Time frame
severe PPH (>1000 cc), .	first 24 hours

Contacts

Primary Contactahmed Dr alanwar, MD

eladwar@hotmail.com+201111486669

Backup Contactahmed Dr kotb, MD

ahmedmkotp@hotmail.com+201008681999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026